Chronic PainNCT04263324
Beneficial Effects of Self-hypnosis/Self-care for Chronic Pain Patients : a MRI and EEG Study
A study testing Self-hypnosis/self-care in people with Chronic Pain, run by University of Liege at 1 site in Belgium.
Trial summary
Chronic pain concerns one in four adults in Belgium. Fibromyalgia is an example of chronic pain and is characterized by diffused and migrant musculo-tendinous pain localized in the limbs and at an axial level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Self-hypnosis/self-care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major
- Fluency in French
- Fibromyalgia diagnosis
Who cannot join
- Neurologic disorder
- Psychiatric disorder
- Drug addiction
- Alcoholism
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hospital University of Liège
Liège, 4000
Audrey Vanhaudenhuyse, PhD, +3243668482, avanhaudenhuyse@chuliege.be
Aminata Bicego, PhD Student, +3243663499, abicego@uliege.be
About this study
Official title: Beneficial Effects of Self-hypnosis/Self-care Learning Program for Chronic Pain Patients : a MRI and EEG Study
Chronic pain concerns one in four adults in Belgium. Fibromyalgia is an example of chronic pain and is characterized by diffused and migrant musculo-tendinous pain localized in the limbs and at an axial level. The technological improvement in neuroimaging allowed to improve, at a cerebral level, the identification of the structural and the functional characteristics of this clinical entity. Studies indicated a modification in cerebral morphometry showing an alteration of white and grey matter in the anterior cingulate cortex, orbitofrontal lateral cortex, cerebellum, basal ganglia, insula, secondary somatosensory cortex, thalamus, amygdala, putamen, superior temporal gyrus and periaqueductal grey matter. At a functional level, studies show un alteration in the connectivity of the default mode network, an atrophy of zones implicated in nociception and an increased activation of zone implicated in response to a nociceptive stimulus.
Nowadays, researchers are interested in finding out the beneficial effects of non-pharmacological techniques to improve de well-being of patients with chronic pain. Hypnosis is one of these techniques that has already proven to be successful in decreasing pain and improving global quality of life. Nevertheless, to our knowledge, no study has been conducted to understand the impact of hypnosis upon the cerebral functioning of these patients. Therefore, the aim of this study is to understand the impact of a 6 months self-hypnosis/self-care learning program upon the structural and functional functioning of the brain by means of functional magnetic resonance imagery (fMRI) and electroencephalography (EEG).
- Conditions
- Chronic Pain
- Being tested
- Self-hypnosis/self-care
- Keywords
- chronic pain, fibromyalgia, hypnosis, fMRI, EEG
- Medical subject headings
- Chronic Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-hypnosis/self-careBehavioural
Learning phase of self-hypnosis/self-care.
| Study group | Role | What they receive |
|---|---|---|
| Self-hypnosis/self-care group | Experimental | It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day. Receives: Behavioral: Self-hypnosis/self-care |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain description
The impact of self-hypnosis/self-care on pain description will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (no pain) to 10 (worst pain).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in sleep difficulties
The impact of self-hypnosis/self-care upon the severity of insomnia will be assessed by means of the "Insomnia Severity Index" (Morin et al., 2001). Scale ranging from 0 (none) to 4 (very severe).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in anxiety
The impact of self-hypnosis/self-care on anxiety will be assessed by means of the subtest "anxiety" of the Hospital Anxiety and Depression Scale (HADS, Zigmond \& Snaith, 1983). Scale ranging from 0 (never) to 4 (always).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in depression
The impact of self-hypnosis/self-care on depression will be assessed by means of the subtest "anxiety" of the Hospital Anxiety and Depression Scale (HADS, Zigmond \& Snaith, 1983). Scale ranging from 0 (never) to 4 (always).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in pain disability
The impact of self-hypnosis/self-care on pain disability will be assessed by means of the "Pain Disability Index" (PDI, Tait et al., 1990). Scale ranging from 0 (no difficulties) to 10 (a lot of difficulties).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in attitudes and beliefs about pain
The impact of self-hypnosis/self-care on the attitudes and beliefs about pain will be assessed my means of the "Survey of Pain Attitudes" (SOPA, Jensen \& Karoly, 1987). Scale ranging from 0 (totally wrong) to 10 (totally right).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in quality of life
The impact of self-hypnosis/self-care on the quality of life will be assessed by means of the "Short Form-36"(SF-36; Ware et al., 1988). Each item is balanced to obtain a score between 0 (worst quality) to 100 (maximum quality).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in locus of control
The impact of self-hypnosis/self-care on the locus of control will be assessed my means og the "Multidimensional Health Locus of Control" (MHLC, Wallston et al., 1978). Scale ranging from 1 (no agreement) to 4 (agreement).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change of the impact of pain
The impact of self-hypnosis/self-care on the impact of pain in individual's life, quality of social support and general activity, will be assessed my means of the "Multidimensional Pain Index" (PDI, Kerns et al., 1985). Scale ranging from 0 (none) to 6 (a lot).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in generic health
The impact of self-hypnosis/self-care on generic health will be assessed by the "EuroQol 5 Dimensions" questionnaire (EQ-5D, Health Policy, 1990). Scale ranging from 1 (no problems) to 3 (extreme problems).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in health status
The impact of Self-hypnosis/self-care on global health status will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (worst health status) to 100 (best health status).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Change in physical activity
The impact of self-hypnosis/self-care on the physical activity will be assessed by means of the International Physical Activity Questionnaire (Craig et al., 2003). Participants have to describe the amount of low to intense physical activity they did over a period of 7 days.
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Motivation to change
The impact of self-hypnosis/self-care on the motivation to change will be assessed by means of the "University of Rhode Island Change Assessment" (URICA, DiClemente et al., 1990). Scale ranging from 1 (no agreement) to 5 (agreement).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Impact on return-to-work
For participants who continued to work at time of inclusion, the "Work Design Questionnaire" (WDQ, Morgeson \& Hymphrey, 2006) will be administered. Scale ranging from 0 (not at all) to 5 (exactly).
Measured: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Sep 2019
- Primary completion31 Jan 2020 (estimated)
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Each patients will have a medical and a psychological consultation and will have to fill-in questionnaires (T0). Then, they will receive a psycho-education training (5 sessions) and will have to complete the same questionnaires (T1). After that, they will again have a medical (pain doctor) and a psychological consultation. Afterwards, the care staff will have a multidisciplinary discussion about their diagnosis. Then functional Magnetic Resonance Imaging (fMRI; 1 hour) and HdEEG (1 hour) data will be acquired in resting state. After that, participants will receive a 7 months (2 hours session a month) learning program of self-hypnosis/self-care animated by a therapist specialized in hypnosis. After the 7 months learning-program they will complete the same questionnaires (T2) and be scanned again by means of fMRI and HdEEG. Patient who do not want to participate to the learning program will not have a treatment but will be scanned in the fMRI and the HdEEG.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Benoit
- Responsible party
- Principal investigator, Audrey Vanhaudenhuyse, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263324
- Sponsor's protocol ID
- 2017/291
- Status last verified
- Feb 2020
- First submitted
- 2 Jan 2020
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kumar Govindaiah P, Adarsh A, Panda R, Gosseries O, Malaise N, Salamun I, Tshibanda L, Laureys S, Bonhomme V, Faymonville ME, Vanhaudenhuyse A, Bicego A. Exploring Electrophysiological Responses to Hypnosis in Patients with Fibromyalgia. Brain Sci. 2024 Oct 23;14(11):1047. doi: 10.3390/brainsci14111047.
PubMed 39595811
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Self-hypnosis/Self-care Learning Program for Chronic Pain Patients : a MRI and EEG Study
- ClinicalTrials.gov ID
- NCT04263324
- Acronym / sponsor ID
- 2017/291
- Conditions
- Chronic Pain
- Keywords
- chronic pain, fibromyalgia, hypnosis, fMRI, EEG
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Collaborators
- Fondation Benoit
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic pain concerns one in four adults in Belgium. Fibromyalgia is an example of chronic pain and is characterized by diffused and migrant musculo-tendinous pain localized in the limbs and at an axial level. The technological improvement in neuroimaging allowed to improve, at a cerebral level, the identification of the structural and the functional characteristics of this clinical entity. Studies indicated a modification in cerebral morphometry showing an alteration of white and grey matter in the anterior cingulate cortex, orbitofrontal lateral cortex, cerebellum, basal ganglia, insula, secondary somatosensory cortex, thalamus, amygdala, putamen, superior temporal gyrus and periaqueductal grey matter. At a functional level, studies show un alteration in the connectivity of the default mode network, an atrophy of zones implicated in nociception and an increased activation of zone implicated in response to a nociceptive stimulus.
Nowadays, researchers are interested in finding out the beneficial effects of non-pharmacological techniques to improve de well-being of patients with chronic pain. Hypnosis is one of these techniques that has already proven to be successful in decreasing pain and improving global quality of life. Nevertheless, to our knowledge, no study has been conducted to understand the impact of hypnosis upon the cerebral functioning of these patients. Therefore, the aim of this study is to understand the impact of a 6 months self-hypnosis/self-care learning program upon the structural and functional functioning of the brain by means of functional magnetic resonance imagery (fMRI) and electroencephalography (EEG).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each patients will have a medical and a psychological consultation and will have to fill-in questionnaires (T0). Then, they will receive a psycho-education training (5 sessions) and will have to complete the same questionnaires (T1). After that, they will again have a medical (pain doctor) and a psychological consultation. Afterwards, the care staff will have a multidisciplinary discussion about their diagnosis. Then functional Magnetic Resonance Imaging (fMRI; 1 hour) and HdEEG (1 hour) data will be acquired in resting state. After that, participants will receive a 7 months (2 hours session a month) learning program of self-hypnosis/self-care animated by a therapist specialized in hypnosis. After the 7 months learning-program they will complete the same questionnaires (T2) and be scanned again by means of fMRI and HdEEG. Patient who do not want to participate to the learning program will not have a treatment but will be scanned in the fMRI and the HdEEG.
| Arm | Type | Receives |
|---|---|---|
| Self-hypnosis/self-care group | Experimental | Behavioral: Self-hypnosis/self-careIt is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day. |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major
- Fluency in French
- Fibromyalgia diagnosis
Key exclusion criteria (4 listed)
- Neurologic disorder
- Psychiatric disorder
- Drug addiction
- Alcoholism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-hypnosis/self-careLearning phase of self-hypnosis/self-care. | Behavioural | Self-hypnosis/self-care group |
Primary outcome
Change in pain description
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on pain description will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (no pain) to 10 (worst pain).
Change in sleep difficulties
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care upon the severity of insomnia will be assessed by means of the "Insomnia Severity Index" (Morin et al., 2001). Scale ranging from 0 (none) to 4 (very severe).
Change in anxiety
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on anxiety will be assessed by means of the subtest "anxiety" of the Hospital Anxiety and Depression Scale (HADS, Zigmond \& Snaith, 1983). Scale ranging from 0 (never) to 4 (always).
Change in depression
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on depression will be assessed by means of the subtest "anxiety" of the Hospital Anxiety and Depression Scale (HADS, Zigmond \& Snaith, 1983). Scale ranging from 0 (never) to 4 (always).
Change in pain disability
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on pain disability will be assessed by means of the "Pain Disability Index" (PDI, Tait et al., 1990). Scale ranging from 0 (no difficulties) to 10 (a lot of difficulties).
Change in attitudes and beliefs about pain
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on the attitudes and beliefs about pain will be assessed my means of the "Survey of Pain Attitudes" (SOPA, Jensen \& Karoly, 1987). Scale ranging from 0 (totally wrong) to 10 (totally right).
Change in quality of life
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on the quality of life will be assessed by means of the "Short Form-36"(SF-36; Ware et al., 1988). Each item is balanced to obtain a score between 0 (worst quality) to 100 (maximum quality).
Change in locus of control
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on the locus of control will be assessed my means og the "Multidimensional Health Locus of Control" (MHLC, Wallston et al., 1978). Scale ranging from 1 (no agreement) to 4 (agreement).
Change of the impact of pain
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on the impact of pain in individual's life, quality of social support and general activity, will be assessed my means of the "Multidimensional Pain Index" (PDI, Kerns et al., 1985). Scale ranging from 0 (none) to 6 (a lot).
Change in generic health
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on generic health will be assessed by the "EuroQol 5 Dimensions" questionnaire (EQ-5D, Health Policy, 1990). Scale ranging from 1 (no problems) to 3 (extreme problems).
Change in health status
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of Self-hypnosis/self-care on global health status will be assessed by means of a Visual Analogue Scale (VAS). Scale ranging from 0 (worst health status) to 100 (best health status).
Change in physical activity
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on the physical activity will be assessed by means of the International Physical Activity Questionnaire (Craig et al., 2003). Participants have to describe the amount of low to intense physical activity they did over a period of 7 days.
Motivation to change
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
The impact of self-hypnosis/self-care on the motivation to change will be assessed by means of the "University of Rhode Island Change Assessment" (URICA, DiClemente et al., 1990). Scale ranging from 1 (no agreement) to 5 (agreement).
Impact on return-to-work
Time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)
For participants who continued to work at time of inclusion, the "Work Design Questionnaire" (WDQ, Morgeson \& Hymphrey, 2006) will be administered. Scale ranging from 0 (not at all) to 5 (exactly).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Derived from this study: PubMed 39595811Kumar Govindaiah P, Adarsh A, Panda R, Gosseries O, Malaise N, Salamun I, Tshibanda L, Laureys S, Bonhomme V, Faymonville ME, Vanhaudenhuyse A, Bicego A. Exploring Electrophysiological Responses to Hypnosis in Patients with Fibromyalgia. Brain Sci. 2024 Oct 23;14(11):1047. doi: 10.3390/brainsci14111047.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-hypnosis/self-care in people with Chronic Pain, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Audrey Vanhaudenhuyse, PhD (+3243668482, avanhaudenhuyse@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain description (time frame: Day 0 (first meeting with the doctor), up to 5 months (before the intervention), up to 12 months (after the intervention)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04263324, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.